Drug Product Process Development Engineer

Drug Product Process Development Engineer

Drug Product Process Development Engineer Description
Function
Drug Product Process Development Engineer Location / Contact
AC Immune SA, EPFL Innovation Park, Building B, 1015 Lausanne E-Mail schreiben Percentage
100 %
Reporting Line
DP Manufacturing Science and Technology Group Leader Overview
AC Immune is a clinical-stage Swiss Biotech Company focused on the development of innovative therapeutics and diagnostics for Alzheimer's and other neurodegenerative diseases. Job description
The Drug Product Process Development Engineer will assist the technology transfer, process optimization and scale-up for all drug product manufacturing development activities to contract manufacturing organizations. The candidate will also assist buildup of in-house vaccine manufacturing capabilities to facilitate industrialization of newly developed processes. Key responsibilities

• Assist technology transfer and scale-up of all manufacturing activities until GMP production. Carry out risk analyses and PFMEA on manufacturing processes
• Liaise internally within AC Immune and externally with CMOs to fill identified gaps and/or mitigate risks to ensure successful technology transfers
• Plan and monitor the engineering runs. Carry out process performance analysis
• Assist initiation of GMP manufacturing activities
• Ensure mirroring of manufacturing processes between AC Immune and CMOs
• Identify pilot-scale equipment suitable for in-house manufacturing activities, contact external vendors, carry out RFI/RFP process to assess equipment/system suitability to build these capabilities
• Contribute to maintenance of inventory of materials and consumables used by the MFG team
• Support budget preparation related to in-house operations

Qualifications
Qualifications:

• Bachelor or MSc in process engineering, pharmaceutical engineering, systems engineering, mechanical engineering or similar
• Has at least 5 years of industrial experience, with expertise in multiple types of industrial equipment and processes (mixers, filtration, purification devices).
• Has proven expertise in failure mode analysis and process performance analysis.
• Has demonstrated ability to solve complex engineering challenges in highly dynamic environments with internal and external stakeholders
• Has demonstrated ability to analyze data and generate reports Personal features include:
  
• Strong technical acumen
  
• Ability to integrate and learn fast
• Strong interpersonal skills for efficient collaboration with all colleagues
• Fluency in spoken and written English